Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-05 @ 1:15 PM
Study NCT ID:
NCT03094156
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2017-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'C071192', 'term': 'entacapone'}], 'ancestors': [{'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2006-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2017-03-28', 'lastUpdatePostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day 4 - Maximum observed plasma drug concentration (Cmax)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4'}, {'measure': 'Day 4 - Time of occurrence of Cmax (tmax)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4'}, {'measure': 'Day 4 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4'}, {'measure': 'Day 4 - AUC from time zero to 8 h post-dose (AUC0-τ)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4'}, {'measure': 'Day 4 - Apparent terminal elimination half-life, calculated from ln 2/λz (t1/2)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4'}, {'measure': 'Day 4 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8 and 16 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 4'}, {'measure': 'Day 5 - Maximum observed plasma drug concentration (Cmax)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose'}, {'measure': 'Day 5 - Time of occurrence of Cmax (tmax)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5'}, {'measure': 'Day 5 - Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5'}, {'measure': 'Day 5 - AUC from time zero to 8 h post-dose (AUC0-τ)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5'}, {'measure': 'Day 5 - Apparent terminal elimination half-life, calculated from ln 2/λz (t1/2)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5'}, {'measure': 'Day 5 - Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞)', 'timeFrame': 'pre-dose, ¼, ½, ¾, 1, 1½, 2, 3, 4, 6, 8, 16 and 24 hours post-dose', 'description': 'BIA 6-512, levodopa, 3-OMD and entacapone pharmacokinetic parameters on day 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to To investigate whether the administration of BIA 6-512 (25 mg, 50 mg, 75 mg and 100 mg) at steady-state affects the pharmacokinetics of levodopa when administered in combination with a single-dose of immediate release levodopa/benserazide 200/50 mg or with a single-dose of immediate release levodopa/benserazide 200/50 mg plus a single-dose of entacapone 200 mg.', 'detailedDescription': 'Single centre, double-blind, randomised, placebo-controlled, rising multiple-dose study in four sequential groups of healthy male and female subjects. Eligible subjects were admitted to the Human Pharmacology Unit (UFHBIAL - Portela \\& Cª, SA) on the day prior to receiving the first study medication. Starting in the morning of Day 1 (first dose), subjects received BIA 6-512/Placebo thrice-daily until the morning of Day 5 (last dose). Concomitantly with the morning dose of BIA 6-512/Placebo, on Day 4 a levodopa/benserazide 200/50 mg (Madopar® 250) single-dose was administered. On Day 5, a Madopar® 250 single-dose and a entacapone 200 mg (Comtan®) single-dose were administered concomitantly with the morning dose of BIA 6-512/Placebo. In the morning of Day 4 and Day 5, products were administered in fasting of at least 8 hours and subjects remained fasted until 2 h post-dose. Subjects were resident in the UFH from admission (Day 0) until at least 24 h post last dose (Day 6); then, they were discharged and returned for the follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects aged between 18 and 45 years, inclusive.\n* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.\n* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.\n* Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening\n* Subjects who had clinical laboratory test results clinically acceptable at screening and admission.\n* Subjects who had a negative screen for alcohol and drugs of abuse at screening and admission.\n* Subjects who were non-smokers or who smoked ≤ 10 cigarettes or equivalent per day.\n* Subjects who were able and willing to gave written informed consent.\n* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.\n* (If female) She had a negative urine pregnancy test at screening and admission.\n\nExclusion Criteria:\n\n* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.\n* Subjects who had a clinically relevant surgical history.\n* Subjects who had a clinically relevant family history.\n* Subjects who had a history of relevant atopy.\n* Subjects who had a history of relevant drug hypersensitivity.\n* Subjects who had a history of alcoholism or drug abuse.\n* Subjects who consumed more than 14 units of alcohol a week.\n* Subjects who had a significant infection or known inflammatory process on screening or admission.\n* Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission.\n* Subjects who had used medicines within 2 weeks of admission that may affect the safety or other study assessments, in the investigator's opinion.\n* Subjects who had previously participated in a clinical trial with BIA 6-512.\n* Subjects who had used any investigational drug or participated in any clinical trial within 6 months prior to screening.\n* Subjects who had participated in more than 2 clinical trials within the 12 months prior to screening.\n* Subjects who had donated or received any blood or blood products within the 3 months prior to screening.\n* Subjects who were vegetarians, vegans or have medical dietary restrictions.\n* Subjects who cannot communicate reliably with the investigator.\n* Subjects who were unlikely to co-operate with the requirements of the study.\n* Subjects who were unwilling or unable to give written informed consent.\n* (If female) She was pregnant or breast-feeding.\n* (If female) She was of childbearing potential and she did not use an effective contraceptive method (double-barrier, intra-uterine device or abstinence) or she used oral contraceptives."}, 'identificationModule': {'nctId': 'NCT03094156', 'briefTitle': 'Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg', 'orgStudyIdInfo': {'id': 'BIA-6512-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the Placebo morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the Placebo morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.', 'interventionNames': ['Drug: Placebo', 'Drug: Madopar® 250', 'Drug: Comtan®']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 6-512 25 mg', 'description': 'Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 25 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 25 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.', 'interventionNames': ['Drug: BIA 6-512', 'Drug: Madopar® 250', 'Drug: Comtan®']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 6-512 50 mg', 'description': 'Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 50 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 50 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.', 'interventionNames': ['Drug: BIA 6-512', 'Drug: Madopar® 250', 'Drug: Comtan®']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 6-512 75 mg', 'description': 'Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 75 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 75 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.', 'interventionNames': ['Drug: BIA 6-512', 'Drug: Madopar® 250', 'Drug: Comtan®']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 6-512 100 mg', 'description': 'Subjects were administered with those investigational products at approximately 8-h intervals, starting in the morning (approximately at 8h00) of Day 1 and finishing in the morning of Day 5 (last dose). On Day 4, concomitantly with the BIA 6-512 100 mg morning dose, one tablet of Madopar® 250 was administered. On Day 5, concomitantly with the BIA 6-512 100 mg morning dose, one tablet of Madopar® 250 and one tablet of Comtan® were administered.', 'interventionNames': ['Drug: BIA 6-512', 'Drug: Madopar® 250', 'Drug: Comtan®']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': '1 capsule of placebo \\[to be taken orally, with 240 mL of potable water\\]', 'armGroupLabels': ['Placebo']}, {'name': 'BIA 6-512', 'type': 'DRUG', 'otherNames': ['Trans-resveratrol'], 'description': '1 capsule of BIA 6-512 25mg or 1 capsule of BIA 6-512 50 mg or 1 capsule of BIA 6-512 75 mg or 1 capsule of BIA 6-512 100 mg \\[to be taken orally, with 240 mL of potable water\\]', 'armGroupLabels': ['BIA 6-512 100 mg', 'BIA 6-512 25 mg', 'BIA 6-512 50 mg', 'BIA 6-512 75 mg']}, {'name': 'Madopar® 250', 'type': 'DRUG', 'description': 'Levodopa/benserazide immediate release tablets 200mg/50mg \\[to be taken orally, with 240 mL of potable water\\]', 'armGroupLabels': ['BIA 6-512 100 mg', 'BIA 6-512 25 mg', 'BIA 6-512 50 mg', 'BIA 6-512 75 mg', 'Placebo']}, {'name': 'Comtan®', 'type': 'DRUG', 'description': 'Entacapone 200 mg tablets \\[to be taken orally, with 240 mL of potable water\\]', 'armGroupLabels': ['BIA 6-512 100 mg', 'BIA 6-512 25 mg', 'BIA 6-512 50 mg', 'BIA 6-512 75 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4745-457', 'city': 'S. Mamede Do Coronado', 'country': 'Portugal', 'facility': 'Human Pharmacology Unit (UFH) - BIAL - Portela & Cª, SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}